Clinical Evaluation Comprehensive data analysis and medical writing expertise

Market-leading Clinical Evaluation and CER-writing service delivered by highly-skilled medical professionals.

Bringing medical expertise to Clinical Evaluation

MDR Clinical Evaluation requires a detailed analysis of safety and performance data from multiple sources. It must be performed for all medical devices and summarised in a Clinical Evaluation Report (CER).

Our team of MDR-trained medical professionals are experts at applying their clinical knowledge and data analysis capabilities to MDR Clinical Evaluation.

  • Data analysis & literature searching

    Meet MDR requirements for Clinical Evaluation through objective and comprehensive data analysis, assimilation and interpretation.

  • CER-writing service

    The medical writing capabilities of medical professionals brought directly to your CER.

  • Efficient and cost-effective

    All the benefits of engaging highly-trained clinical data specialists without the costs and inconvenience of workforce expansion.

Our Clinical Evaluation process

Mantra Systems' Clinical Evaluation process

Our Clinical Evaluation process begins with a free consultation & quote to discuss your requirements.

Comprehensive analysis of internal and external data against MDR standards enables production of professional CERs written by our medical experts.

Medical device Clinical Evaluation ready for the MDR

Clinical Evaluation involves a detailed analysis of clinical data to assess compliance with relevant MDR Annex I GSPRs and the benefit-risk profile of the device.

Our highly-skilled team will analyse and interpret your clinical data in order to satisfy the rigourous standards for Clinical Evaluation under the MDR.

  • Direct access to medical professionals

    Get detailed insights from our highly-trained professionals throughout the clinical evaluation process.

  • 360° Clinical Evaluation

    We handle the entire process from start-to-finish and produce market-leading CERs.

  • Adherence to all relevant standards

    Clinical Evaluation in accordance with MDR Annex XIV and MEDDEV 2.7/1 rev 4.

Call us now to discuss your MDR requirements:

(+44) 0114 386 3349

Or send us your details and we will contact you:

Who we work with

Our clients come from across the industry and range from pre-start businesses to stockmarket-listed multinationals. We aslo have key strategic partners based in the UK and Denmark.

  • It was a pleasure working with you. We are completely satisfied with your service and look forward to working with you again in future.

    CEO, EU medical software company
  • Your service surpassed our expectations and added value across our organisation. We now feel much better placed to prepare for the MDR.

    Chief Executive, MedTech pre-start
  • A comprehensive, detailed and highly professional service.

    Regulatory Manager, UK device manufacturer
  • International

    We work with medical device manufacturers based in the UK, Europe, the US and Asia, developing MDR strategies for both physical devices and software as a medical device.

  • Diversified

    Working with us gives you access to our growing international team of MDR-trained healthcare professionals from a wide variety of clinical backgrounds.

MDR Consulting

Our team of medical professionals are specialists at building the clinical evidence portfolio that you need for MDR compliance of your products.

Download our free Mastering the MDR White Paper — An easily digestible summary of the EU MDR

Download

MDR Training

Our comprehensive training services are delivered by experts and address all aspects of MDR compliance.

MDR Guidance

Our unique MDR guidance resources are written by our medical experts and free to use. They cover all aspects of the new Medical Device Regulation.

FAQs

We have compiled some of our frequently asked questions. If you'd like to know anything else about what we do, feel free to ask us a question.

  1. We can work with the majority of medical device manufacturers seeking compliance of their devices in accordance with Regulation (EU) 2017/745, including both hardware and software devices. We also offer a free, no-obligation consultation, so please feel confident about discussing your requirements with a member of our team.

  2. No. We will work with you to produce systems and to support your EU MDR compliance, but we do not conduct research ourselves. We will provide tools for you to conduct your own Post-Market Surveillance. Our range of services are designed to assist you in this matter.

  3. Yes. We adhere to the highest standards of professionalism and regard maintaining confidentiality and data security as a cornerstone of our practice. We also comply fully with the requirements of GDPR.

  4. Our services are built around a strict quality framework and we only work with clients who share this commitment to quality. Our CEO is a medical doctor with years of experience in the medical device industry and assumes personal responsibility for every project. Our product development process integrates client feedback throughout product production, ensuring a constant focus on your needs.

  5. We work with clients of all sizes and at all stages of their regulatory compliance journey. Our team are here to help and are happy to respond to general enquiries, even if you don't feel like you know where to start. We are experts at 'tuning in' to your requirements and will guide you through the entire process. Our free MDR Compliance Guide and suite of MDR downloads stand as proof of our commitment to help you understand your obligations under the MDR.

  6. Yes. Software as a medical device is an increasingly-important segment of the medical device market. We have extensive experience in building regulatory systems for medical software and offer a special application of all our MDR services for software products. We also offer unique downloads and white papers that focus specifically on software as a medical device.

  7. At its core, working with the MDR is about working with clinical evidence. Whether you need to generate evidence for PMCF, analyse data for writing a CER, or build an MDR-ready PMS system, our medical experts have the clinical acumen to ensure that your clinical evidence is produced and interpreted with the highest levels of professionalism. Medical professionals work with clinical evidence all day. We bring their specialist capabilities directly to your MDR strategy.

  8. We believe in transparency and aim to build long-term relationships with our clients. This commitment is demonstrated by our customer-focused pricing strategy. You pay a small deposit upfront, only paying the balance when the work has been completed to your total satisfaction. For higher-value projects we offer flexible payment packages on an individual basis — please contact a member of our team to find out more.

  9. Yes. Our unique business model allows us to scale to accommodate almost any amount of work. Many of our medical professionals remain clinically active, meaning that we have trained more than we presently need. This system allows us to have ready availability of redundant capacity that can be called upon in the event of a surge in demand. Whatever your requirements, our unique business model allows us to step in faster than any of our competitors.

  10. Yes. We run a number of events throughout the year focusing on specific aspects of MDR compliance. We also offer a limited number of free webinars on a limited basis — subscribe to our newsletter to be notified early when we publish new events. Of course, we also have our extensive MDR Compliance Guide and free MDR downloads suite, both of which offer extensive training on all aspects of MDR compliance.

Do you have any questions about our MDR services?

Contact us

Let's talk…